DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM11 SERIES

System, Measurement, Blood-pressure, Non-invasive

GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED

The following data is part of a premarket notification filed by Grandway Technology (shenzhen) Limited with the FDA for Digital Automatic Blood Pressure Monitor Bpm11 Series.

Pre-market Notification Details

Device IDK120675
510k NumberK120675
Device Name:DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM11 SERIES
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED ZHU KENG INDUSTRIAL ZONE PING SHAN, LONG GANG DISTRICT Shenshen, Guang Dong,  CN 518118
ContactPatrick Chow
CorrespondentPatrick Chow
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED ZHU KENG INDUSTRIAL ZONE PING SHAN, LONG GANG DISTRICT Shenshen, Guang Dong,  CN 518118
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-03-05
Decision Date2013-02-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04895045403598 K120675 000
00853455007144 K120675 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.